Thursday, 9 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
I do not support amendment (3) or indeed amendments (1) and (2) put up by Senators Colbeck and Scullion. These amendments are designed to prop up the claims made by opponents of the bill that the current arrangement is justified because of the parliamentary scrutiny that is inherent in the current system. But it was pointed out by me and by many others that, despite what the minister and others were claiming, the parliament had no say. The minister was merely required to advise the parliament that he had given approval to an abortifacient—no debate, no vote, no accountability, no criteria.
These amendments are designed to take away the power from the minister. Indeed, they cut the minister out of the question altogether. But this is still flawed, because it leaves the decision to parliamentarians. There are, again, no grounds or criteria for the decision. There are no other pharmaceuticals subject to this regime. The debate would again be about abortion, not about safety and efficacy. As Senator Troeth has pointed out, this place is not in any position to make a judgment about safety and efficacy in any case. It has been said ad nauseam in this debate that abortion is a state and territory matter already decided many years ago and that it does not need revisiting.
These amendments allow the TGA to evaluate RU486, but, if the TGA approves the availability and allows it to be registered or listed, the certificates of registration and listing are disallowable instruments. That means that before RU486 can be made available, even if it can be determined by the TGA to be safe and effective, the parliament is allowed to override that decision. That means that parliamentarians, as I said, are still making the decision, not the body with the expertise, the TGA.
If the drug is determined by the TGA to be safe then the only reason that someone could have for overriding that decision is opposition to abortion per se. By introducing individual moral beliefs into the decision-making process, the proposers of the amendment are giving their own moral beliefs greater precedence than the safety of the drug and the values and experiences of women and their doctors in making the decision. Members of parliament, like all Australians, are entitled to differing views regarding abortion but they are not entitled to use the power of the state and legislation, I would argue, to impose their own personal moral positions on others or to block access to a drug if it has already been proved to be safe for legal medical procedure.
There is also the question of the great disincentive this would provide for sponsors of this drug. They will spend a great deal of money going through the TGA approval process—or will they, knowing that the parliament may well veto that decision by the TGA? So, again, we are going to see the situation of sponsors not coming forward to make it available in this country. I think there will be debate over and over again in this place and, again, it will be over and over about abortion. Will sponsors of abortifacients retry? In which case it comes back to the parliament. Will there be new applications on the basis of new drugs that are abortifacients that will have to go through this process? How much time will be spent tied up in this debate in this place is anyone’s guess. I am not supporting these amendments. We will also not support the removal of the schedule that is inherent in amendments (1) and (2) to follow.
That the amendment (Senator Colbeck’s and Senator Scullion’s) be agreed to.